Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Ramucirumab
Eli Lilly Nederland B.V.
L01FX
ramucirumab
Antineoplastic agents
Stomach Neoplasms
Gastric cancerCyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.Colorectal cancerCyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5‑fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.Non-small cell lung cancerCyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.Hepatocellular carcinomaCyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.
Revision: 16
Authorised
2014-12-19
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER CYRAMZA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION ramucirumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cyramza is and what it is used for 2. What you need to know before you are given Cyramza 3. How you are given Cyramza 4. Possible side effects 5. How to store Cyramza 6. Contents of the pack and other information 1. WHAT CYRAMZA IS AND WHAT IT IS USED FOR Cyramza is a cancer medicine that contains the active substance ramucirumab, which is a monoclonal antibody. This is a specialised protein that can recognise and attach to another protein found on blood vessels called ‘VEGF receptor 2’. This receptor is needed in the development of new blood vessels. To grow, cancer needs new blood vessels to develop. By attaching to ‘VEGF receptor 2’ and blocking it the medicine cuts off the blood supply to the cancer cells. Cyramza is given in combination with paclitaxel, another anti-cancer medicine, for the treatment of advanced stomach cancer (or cancer of the junction between the oesophagus and the stomach) in adults whose disease has worsened after treatment with medicines to treat cancer. Cyramza is used for the treatment of advanced stomach cancer (or cancer of the junction between the oesophagus and the stomach) in adults whose disease has worsened after treatment with medicines to treat cancer and for whom treatment of Cyramza in combination with paclitaxel is not suitable. Cyramza is used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults. It is given with other medicines called ‘FOLFIRI chemotherapy’, including ‘5-fluorouracil’, ‘folinic acid Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cyramza 10 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate for solution for infusion contains 10 mg ramucirumab. Each 10 ml vial contains 100 mg of ramucirumab. Each 50 ml vial contains 500 mg of ramucirumab. Ramucirumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology. Excipient with known effect Each 10 ml vial contains approximately 17 mg sodium. Each 50 ml vial contains approximately 85 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear to slightly opalescent and colourless to slightly yellow solution, pH 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1). Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1). Colorectal cancer Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. 3 Non-small cell lung cancer Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations (see section 5.1). Cyramza in combination Přečtěte si celý dokument